Back to resultsPD-L1 Expression in Cancer (PECan Study). (PECan)
Primary Purpose
Non-small Cell Lung Cancer, Melanoma
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
[99mTc]-NM-01 SPECT/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or above
- Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.
- Willingness and ability to comply with scheduled study visits and tests.
Exclusion Criteria:
- Pregnant or lactating women
- Concomitant uncontrolled medical conditions
- Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days
- More than 3 months between IHC PDL1 and study recruitment
- Patients who have received other systemic anti-cancer therapy within preceding 14 days
- Prognosis less than 3 months
- Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients
Sites / Locations
- Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
Arm Description
Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks. FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks. Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks. FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.
Outcomes
Primary Outcome Measures
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change.
Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change.
Standard clinical imaging assessment at 12 and 24 weeks used as comparators.
Secondary Outcome Measures
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.
Full Information
NCT ID
NCT04436406
First Posted
March 9, 2020
Last Updated
December 13, 2022
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
NanoMab Technology (UK) Limited
1. Study Identification
Unique Protocol Identification Number
NCT04436406
Brief Title
PD-L1 Expression in Cancer (PECan Study).
Acronym
PECan
Official Title
Measurement of PD-L1 Expression in Cancer to Monitor Treatment Response.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2020 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
Collaborators
NanoMab Technology (UK) Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Measurement of PD-L1 expression in cancer to monitor treatment response.
A prospective non-blinded, single centre, single interventional arm diagnostic imaging study.
To determine the baseline level and variability within and between patients and tumour types of PD-L1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PD-L1 SPECT/CT and immunohistochemistry.
Detailed Description
Using [99mTc]-labeled anti-PD-L1 single-domain antibody, this study aims to prospectively measure changes in PD-L1 expression determined with SPECT/CT imaging and correlate these changes with response to anti-PD(L)1 immunotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Melanoma
Keywords
immunotherapy, checkpoint inhibitors, molecular imaging, non-small cell lung cancer, melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Advanced malignant disease (non-small cell lung cancer or malignant melanoma)
Arm Type
Experimental
Arm Description
Group 1: Participants with non-small cell lung cancer (NSCLC) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 9 weeks.
FDG-PET/CT is also performed at baseline (0) and first follow-up (9) weeks scans, in addition to standard CT clinical imaging at 0, 9 and 18 weeks.
Group 2: Participants with malignant melanoma (MM) as per inclusion/exclusion criteria undergo baseline PD-L1 expression testing by immunohistochemistry and [99m-Tc]-anti-PD-L1 single-domain antibody SPECT/CT imaging at 0 and 12 weeks.
FDG-PET/CT is also performed as standard clinical imaging at baseline (0), first follow-up (12) weeks and 24 weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
[99mTc]-NM-01 SPECT/CT
Intervention Description
Technetium labelled anti-PD-L1 single-domain antibody (NM-01) single-photon emission computed tomography (SPECT)/CT
Primary Outcome Measure Information:
Title
Percentage change in PD-L1 expression (using [99mTc] SPECT) in NSCLC.
Description
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 9 weeks will be compared to determine % change.
Standard clinical imaging assessment at 9 and 18 weeks used as comparators.
Time Frame
Up to 18 weeks
Title
Percentage change in PD-L1 expression (using [99mTc] SPECT) in melanoma lesions.
Description
PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT. Measurement at baseline and 12 weeks will be compared to determine % change.
Standard clinical imaging assessment at 12 and 24 weeks used as comparators.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Report PD-L1 tumour expression (using [99mTc] SPECT) of immunotherapy naive participants compared to PD-L1 expression determine by standard immunohistochemistry.
Description
Correlation between PD-L1 expression reported by measurement of tumour:blood pool ratio and/or SUV of [99mTc]-anti-PD-L1-sdAb uptake on SPECT and PD-L1 expression determined by standard of care immunohistochemistry.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 or above
Patients with histologically confirmed NSCLC or melanoma scheduled for PD1/PDL1 immunotherapy alone or in combination with other systemic anti-cancer therapy.
Willingness and ability to comply with scheduled study visits and tests.
Exclusion Criteria:
Pregnant or lactating women
Concomitant uncontrolled medical conditions
Patients likely to require palliative radiotherapy within the first 12 weeks of treatment or radiotherapy to target lesion(s) received within preceding 42 days
More than 3 months between IHC PDL1 and study recruitment
Patients who have received other systemic anti-cancer therapy within preceding 14 days
Prognosis less than 3 months
Previous anticancer treatment with any checkpoint inhibitor or other immunotherapy, i.e. only immunotherapy naïve patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel J Hughes, MBBS MRCP
Phone
020 7188 7188
Ext
88378
Email
daniel.hughes@kcl.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary JR Cook
Organizational Affiliation
King's College London, London, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel J Hughes, MBBS MRCP
Phone
(0044)20 7188 7188
Ext
88378
Email
daniel.hughes@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Gary JR Cook
Phone
(0044)20 7188 7188
Ext
88378
Email
gary.cook@kcl.ac.uk
First Name & Middle Initial & Last Name & Degree
Gary JR Cook
First Name & Middle Initial & Last Name & Degree
Daniel J Hughes
12. IPD Sharing Statement
Plan to Share IPD
No
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